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Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days (TQT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00686179
First Posted: May 29, 2008
Last Update Posted: September 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
The purpose of this study is to evaluate the effects on cardiac repolarisation of supratherapeutic doses of AZD3480 compared to placebo in healthy male volunteers, subgrouped as extensive metabolisers and poor metabolisers according to CYP2D6 metabolic capacity, using moxifloxacin as positive control.

Condition Intervention Phase
Healthy Drug: AZD3480 Drug: Moxifloxacin Drug: PLACEBO Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Double-Blind, Randomised, Multicentre, Placebo-Controlled, 4-Ways Crossover Study to Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days, Using Moxifloxacin as a Positive Control, in Healthy Male Volunteers, CYP2D6 Extensive and Poor Metabolisers.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • QTcX interval (supratherapeutic doses in comparison to placebo).Subject-specific correction of QT, QTcF and QTcB (supportive outcome variables).Bazett QTcB=QT*RR-1/2Fridericia QTcF=QT'RR-1/3 [ Time Frame: 11 dECG measurements x 4 (4-way crossover) ]

Secondary Outcome Measures:
  • QTcX (therapeutic doses in comparison to placebo).PR-, QRS-, RR-intervals [ Time Frame: 11 dECG measurements x 4 (4-way crossover) ]
  • Plasma concentration (AUC, Cmax, tmax etc) [ Time Frame: 11 PK-measurements x 4 (4-way crossover) ]
  • Registration of AEs, blood pressure, ECG, clinical laboratory tests [ Time Frame: From enrolment to follow-up ]

Enrollment: 75
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Escalating doses of AZD3480 during 6 days
Drug: AZD3480
Capsule, oral, single dose, 6 days
Other Name: TC-1734-226
Experimental: 2
Repeated doses of AZD3480 during 6 days
Drug: AZD3480
Capsule, oral, single dose, 6 days
Other Name: TC-1734-226
Placebo Comparator: 3
Placebo during 6 days
Drug: PLACEBO
Capsule, oral, single dose
Active Comparator: 4
Placebo during 5 days, active day 6
Drug: Moxifloxacin
Capsule(encapsulated), oral, single dose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participation in a previous study for genotyping for identification to be extensive or poor metaboliser (CYP2D6 enzyme)
  • Physically and mentally healthy male volunteers

Exclusion Criteria:

  • History of clinically significant diseases or illness.
  • Participation in another study the last 3 months
  • Prescribed or non-prescribed medications from 3 weeks prior to first treatment day until follow-up except for paracetamol (max 1.5 g per day.)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686179


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Hans-Göran Hårdemark Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden
  More Information

Responsible Party: Hans-Göran Hårdemark, MD, PhD, Medical Science Director, AZD3480, AstraZeneca R&D, Södertälje, Sweden
ClinicalTrials.gov Identifier: NCT00686179     History of Changes
Other Study ID Numbers: D3690C00004
EUdract NO 2007-004859-11
First Submitted: May 27, 2008
First Posted: May 29, 2008
Last Update Posted: September 25, 2008
Last Verified: September 2008

Keywords provided by AstraZeneca:
TQT
ECG
QT
QTc
AZD3480
ECG(QTc effects)

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs


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